Identity
- Trade Name
- Hegenberger Medical FDA UDI
- Generic Name
- Post-parturition vaginal retractor FDA UDI
- Device Name
- Hegenberger Retractor FDA UDI
- Model / Reference
- A13901 FDA UDI
- Description
- Hegenberger Retractor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05070000986821 FDA UDI
- FDA Product Code
- HDL FDA UDI
- GMDN Term
- Post-parturition vaginal retractor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4520 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Post-parturition vaginal retractor
Hegenberger Medical by Hegenberger Medical Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Post-parturition vaginal retractor.
- Soviflex — Birch Concepts LLC · Class I
- Realstar Surgical — REAL STAR SURGICAL INSTRUMENTS · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hegenberger Medical Limited
Sources (1)
- FDA UDI ff8cafc0-751f-458a-bebf-14cf5a4d8249 33 fields · synced Jun 1, 2026